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FDA 510(k)

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

K-Number: K201832 · 2021-09-17

ApplicantOlympus Medical Systems Corp.
Decision Date2021-09-17
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2021-09-17 under approval number K201832. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5?

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 is a medical device that received FDA 510(k) clearance on 2021-09-17. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K201832.

When was Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 approved by the FDA?

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 received FDA 510(k) clearance on 2021-09-17, under approval number K201832.

What company makes Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5?

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5?

The FDA product code for Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 is HET.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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